Skip to main content

Life Sciences

Renowned as a powerhouse in the life sciences sector, Arnold & Porter is the "go to" law firm for global and emerging life sciences companies seeking effective solutions for their business-defining matters. Our full-service team of 200+ attorneys in the U.S., UK, Europe, and Asia provides comprehensive support and advocacy for life sciences companies throughout the product life cycle — from concept and human trials, through approval and launch, to post-market promotion, compliance, and defense. More than being a convenient "one-stop shop," we are a complete legal lifeline delivering the sophisticated regulatory, transactional, IP, and litigation strategies that innovators need to bring advanced products to patients.

  • Deep Regulatory Experience: Our global team has handled the most challenging life sciences and healthcare regulatory matters, from high-profile global regulatory investigations to unprecedented strategies for obtaining approval.

  • Strategic Litigation Counsel: Viewed as "master strategists," our litigators have a well-established track record resolving large-scale, high-stakes pharmaceutical and medical device disputes.

  • Cutting-Edge Transactions: We assist life science clients with complex transactions involving the most cutting-edge science in the industry and novel deal structures designed to provide beneficial outcomes to all parties in an ever-changing business and scientific landscape.

Arnold & Porter Announces Expansion of Leading European Life Sciences Regulatory Practice with Opening of Amsterdam Office
Insights: Life Sciences | Videos on cutting-edge issues
Life Science highlight box image
Visit our Coronavirus (COVID-19): Legal Resources page
Picture of centrifuge
» Follow Us on LinkedIn & Twitter for the Latest Developments
Life Sciences LinkedIn

Experience Highlights

  • In the COVID-19 crisis, advising clients working on vaccines, drugs, medical devices and diagnostics on emergency use authorizations, funding arrangements with the US and governments globally, the negotiation of global supply chain agreements, and addressing liability concerns.
  • Abbvie in its $63 billion acquisition of Allergan, the manufacturer of the well-known medication Botox. The Wall Street Journal reported that this was one of the biggest mergers in the healthcare sector in the year it was announced.
  • Bayer as national counsel in defending its oral anticoagulant prescription medicine, Xarelto®. The cases were coordinated in an MDL proceeding, as well as coordinated state court proceedings. Based on a successful record of judgments, the companies agreed to a favorable settlement.
  • Boston Scientific in obtaining a $35 million jury verdict in a patent litigation matter involving transcatheter aortic valves while obtaining a complete defense verdict on patent counterclaims; followed by a $180 million global settlement agreement.
  • Bristol-Myers Squibb and Sanofi in ending 12 years of litigation regarding their blood thinner drug, Plavix®, without a single trial or settlement payment.
  • Hologic Inc. and Grifols in securing a complete jury verdict while defending against a $90-million patent claim brought by medical diagnostics company bioMerieux involving HIV-1 detection technology.
  • Major pharmaceutical and medical device companies in responding to critical regulatory matters, including approval strategies, inspections, investigations, FDA Advisory Committee meetings, dispute resolution proceedings, and litigation.
  • AstraZeneca in agreements for the funding and global distribution of the University of Oxford's potential COVID-19 vaccine, as well as in the establishment of its global manufacturing and supply chain for the vaccine, including agreements with the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance (Gavi), the Serum Institute of India (SII), the Biomedical Advanced Research and Development Authority (BARDA) in the US, and the governments of Germany, France, Italy, and the Netherlands.
  • Novartis in the $463 million sale to Mylan of its global cystic fibrosis products, including the TOBI® Podhaler and TOBI® solution.
  • Pharmaceutical Research and Manufacturers of America (PhRMA) at the district level, the US Court of Appeals for the Second Circuit, and the US Supreme Court in a First Amendment challenge to a Vermont law restricting the rights of drug manufacturers to promote their products using prescriber-identifiable data.
  • Pharmaceutical companies in advising on regulatory and litigation risk mitigation strategies for drug products with potential nitrosamine impurities.
Language - English

Focus Areas

Key Contacts

Daniel A. Kracov
Daniel A. Kracov
Partner
Washington, D.C.
+1 202.942.5120
Allison W. Shuren
Allison W. Shuren
Partner
Washington, D.C.
+1 202.942.6525
Rhonda R. Trotter
Rhonda R. Trotter
Partner
Los Angeles;
Silicon Valley
+1 213.243.4153 +1 650.319.4555
See All Related Professionals

Related Services

Recognition

  • Chambers UK
    Life Sciences – UK-wide: Band 1 (2024)
    Life Sciences: Product Liability – UK-wide: Band 1 (2024)
    Life Sciences: Regulatory – UK-wide: Band 1 (2024)
  • Chambers Europe
    Life Sciences (Europe-wide) (2023)
    Life Sciences/European Law (Belgium) (2023)
    Life Sciences (Netherlands) (2023
  • Chambers Global
    Life Sciences (Global-wide) (2024)
    Life Sciences (Europe-wide) (2024)
    Life Sciences and Pharmaceutical Sector (International & Cross-Border) (UK) (2024)
    Life Sciences and Pharmaceutical Sector (International & Cross-Border) (USA) (2024)
    Life Sciences: Regulatory/Compliance (USA) (2024)
  • Law360
    “Life Sciences Practice Group of the Year” (2022)
  • Chambers Greater China Region
    Life Sciences: International Firms (China) (2023-2024)
  • The Legal 500 Asia-Pacific
    Life Sciences and Healthcare: Foreign Firms (China) (2023)
  • LMG Life Sciences Guide
    Impact Deal of the Year (US)—Novartis $1 billion license agreement with BeiGene (2022)
    FDA: Pharmaceutical (2022)
    FDA: Medical Device (2022)
    Healthcare: Pricing and Reimbursement (2022)
    Antitrust (2022)
    Corporate (2022)
    General Patent Litigation (2022)
    Hatch-Waxman Patent Litigation (Branded) (2022)
    Patent Strategy & Management (2022)
    Mergers & Acquisitions (2022)
    Licensing & Collaboration (2022)
    Product Liability (2022)
    White-Collar/Government Investigations (2022)
  • The Legal 500 UK
    Industry Focus: Life Sciences and Healthcare (2023)
  • The Legal 500 U.S.
    Healthcare: Life Sciences (2023)
    Healthcare: Service Providers (2023)
    Product Liability, Mass Tort and Class Action: Pharmaceuticals and Medical Devices—Defense (2022)
  • Chambers USA
    Healthcare: Highly Regarded (Nationwide) (2023)
    Healthcare: Pharmaceutical/Medical Products Regulatory (Washington, D.C.) (2022-2023)
    Healthcare (Washington, D.C.) (2022-2023)
    Life Sciences (Nationwide, California) (2022-2023)
    Life Sciences: Regulatory/Compliance (Nationwide) (2022-2023)
  • Managing Intellectual Property
    "U.S. Firm of the Year" — Life Sciences IP Litigation (2021)
  • Chambers Asia-Pacific
    Life Sciences: International Firms (2021)
  • U.S. News & World Report and Best Lawyers
    "Best Law Firms" for FDA Law (National, Washington D.C.) (2022)
    "Best Law Firms" for Healthcare Law (National, Washington, D.C.) (2022)
    "Best Law Firms" for Biotechnology (National, Washington, D.C., Los Angeles, New York) (2022)
  • Above the Law
    “Outside Counsel Rankings” 2021 — Top counsel in Healthcare/Life Sciences
  • LMG Life Sciences Awards
    Life Cycle Firm of the Year - United States (2022-2023)
    Patent Impact Case of Year - United States: Amgen v Sanofi (U.S. Supreme Ct 2023)